Thyroid CancerECO-THYRNCT03787121
Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers
An observational study of Thyroid Cancer, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The incidence of Thyroid Cancer (TC) has increased over the last thirty years, in France and worldwide. This increase is mainly due to good prognosis microPapillary TC (mPTC). Sixty percent of diagnosed cancers are considered as over-diagnosed, leading to an over-treatment of these cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- care management pathways
- Type of treatment
- Surgery or procedure
- How many people
- 361 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Evathyr database collected by the Oncomip network: Cohort describing the initial management of 423 patients with TC diagnosed in 2014 and passed in the process of Multidisciplinary Team Meeting (MTM).
Who may be able to join
- all patients with a good prognosis of the TC
- diagnosed in 2014
- whose medical file discussed in MultiDisciplinary Team Meeting (MDTM) in Midi-Pyrenees
Who cannot join
- patients whose surgical management was carried out outside Midi Pyrenees are excluded and other morphological types are excluded (medullar, anaplastic, lymphomas, sarcomas)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers : Involvement of Overtreatment
The incidence of Thyroid Cancer (TC) has increased over the last thirty years, in France and worldwide. This increase is mainly due to good prognosis microPapillary TC (mPTC). Sixty percent of diagnosed cancers are considered as over-diagnosed, leading to an over-treatment of these cases. The increase of diagnosis of mPTC and its treatment inevitably leads to an increase of medical resources consumption and corresponding costs.
The primary aim of this study is to estimate the cost related to different care management pathway of TC patient during a lifetime period using a multi-state Markov model.
This is a retrospective, observational population based cohort study, using data from a cohort study of TC patients implemented by the ONCOMIP network which initially aimed to perform an audit of clinical practices for the management of TC, and from database of the French social health insurance of Midi-Pyrenees region to calculate observed costs of TC management during 24 months.
- Conditions
- Thyroid Cancer
- Being tested
- care management pathways
- Keywords
- health economics, care management pathways, overtreatment
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care management pathwaysProcedure or surgery
different care management pathways, including thyroidectomy, iode 131, hormonal treatment and type of follow up
What is being measured
The primary outcome is the main question the study is designed to answer.
cost related to the different management pathways of TC patient
estimate the cost related to the different management pathways of TC patient during a lifetime period using a multi-state Markov model
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Apr 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadège Costa, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787121
- Sponsor's protocol ID
- RC31/17/0378
- Acronym
- ECO-THYR
- Status last verified
- Aug 2021
- First submitted
- 24 Dec 2018
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers : Involvement of Overtreatment
- ClinicalTrials.gov ID
- NCT03787121
- Acronym / sponsor ID
- ECO-THYR / RC31/17/0378
- Conditions
- Thyroid Cancer
- Keywords
- health economics, care management pathways, overtreatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of Thyroid Cancer (TC) has increased over the last thirty years, in France and worldwide. This increase is mainly due to good prognosis microPapillary TC (mPTC). Sixty percent of diagnosed cancers are considered as over-diagnosed, leading to an over-treatment of these cases. The increase of diagnosis of mPTC and its treatment inevitably leads to an increase of medical resources consumption and corresponding costs.
The primary aim of this study is to estimate the cost related to different care management pathway of TC patient during a lifetime period using a multi-state Markov model.
This is a retrospective, observational population based cohort study, using data from a cohort study of TC patients implemented by the ONCOMIP network which initially aimed to perform an audit of clinical practices for the management of TC, and from database of the French social health insurance of Midi-Pyrenees region to calculate observed costs of TC management during 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Evathyr database collected by the Oncomip network: Cohort describing the initial management of 423 patients with TC diagnosed in 2014 and passed in the process of Multidisciplinary Team Meeting (MTM).
Key inclusion criteria (3 listed)
- all patients with a good prognosis of the TC
- diagnosed in 2014
- whose medical file discussed in MultiDisciplinary Team Meeting (MDTM) in Midi-Pyrenees
Key exclusion criteria (1 listed)
- patients whose surgical management was carried out outside Midi Pyrenees are excluded and other morphological types are excluded (medullar, anaplastic, lymphomas, sarcomas)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| care management pathwaysdifferent care management pathways, including thyroidectomy, iode 131, hormonal treatment and type of follow up | Procedure or surgery | – |
Primary outcome
cost related to the different management pathways of TC patient
Time frame: 24 months
estimate the cost related to the different management pathways of TC patient during a lifetime period using a multi-state Markov model
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadège Costa, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cost related to the different management pathways of TC patient (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021; AzTrials last refreshed its copy on 31 Oct 2026.